The Senior Manager, Quality Assurance – Gene Therapy contributes to the on-going enhancement of the total quality system of PTC by leading quality assurance functions related to Good Manufacturing Practice (GMP) compliance for both clinical and marketed Gene Therapy products. This involves working with cross-functional internal teams and Contract Manufacturing Organizations (CMOs) to develop, implement, maintain, and support a quality assurance strategy and plans that contribute to the ability of PTC to achieve and maintain regulatory compliance and ensure product quality in a regulated environment for Gene Therapy products.
The incumbent also works with the PTC Chemistry Manufacturing Control (CMC) and Regulatory Affairs teams to build and maintain quality programs that ensure regulatory compliance. This includes conducting audits and reviewing and approving manufacturing, packaging, and analytical contractor documents. It also includes assisting in the performance of liaison activities related to Food and Drug Administration (FDA) and external US regulatory inspections.
He/she may manage direct reports.
The incumbent works cross-functionally with internal departments and external resources on Quality related issues.
The Senior Manager, Quality Assurance - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Supports the development, implementation and maintenance of the efforts of PTC, both strategic and tactical, to achieve and maintain GxP compliance and quality operations by facilitating compliance with worldwide manufacturing regulations, guidelines, and current regulatory requirements for Gene Therapy products. This involves assisting the Senior Vice President of Quality Assurance in the performance of GxP-related functions which support the position of PTC in a regulated industry domestically and abroad.
Leads and performs Quality Assurance (QA) review and approval of documentation related to contract manufacturing, packaging, labeling, and analytical records, as well as other related documents as required by regulation for Gene Therapy products. This includes the review and approval of:
Manufacturing/packaging records for precursors, Active Pharmaceutical Ingredients (API), drug substance, drug product, and packaging, including but not limited to master batch records, executed batch records, investigations, change orders, and releases;
Packaging and labeling, including changes in components, master copy, new labeling, etc.;
Master plans, protocols, and reports associated with validation at PTC and CMOs, including process and analytical validation activities;
Investigations, incidents, complaints, exceptions, deviations, and Out Of Specification (OOS) reports as generated by CMOs;
Methods and specifications for analytical procedures related to PTC API, drug product, and packaged materials;
Facilitates the successful submission of required paperwork, releases, and other related documents to PTC partners and government agencies both domestic and international for Gene Therapy products.
Actively contributes to the Change Control System by reviewing and approving change control documents in accordance with current QA procedures for Gene Therapy products.
Provides QA support to Regulatory Affairs, CMC and other departments in meeting regulatory compliance and corporate business requirements for Gene Therapy products. This includes, but is not limited to:
Performing the QA review of CMC documentation and other documents submitted to regulatory agencies, including reviewing and approving documented manufacturing, packaging and analytical records;
Assisting in the design of quality systems for GMP regulated departments;
Reviewing SOPs related to Good Manufacturing Practice (GMP).
Performs internal and external audits to assure compliance with GMP regulations.
Supports interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems.
Recommends QA system changes to enhance overall job performance and QA functions and partners with CMO quality peers in overseeing the implementation of these changes.
May manage, coach and mentor direct reports.
Performs other tasks and assignments as needed and specified by management.
Describe the following criteria, which are necessary to effectively perform the position:
* Minimum level of education and years of relevant work experience.
Bachelor’s degree in a scientific discipline and a minimum 6 years progressively responsible experience in a Quality Assurance or related role(s) in a pharmaceutical, biotechnology or related environment, at least 3 years of which should have been in a CMC-focused position (preferably a GMP QA role) with previous management experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Detailed knowledge and understanding of GMP regulations and compliance regulatory requirements.
Experience working in a biological area (Gene Therapy).
Experience working in a Parenteral manufacturing environment.
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
*Special knowledge or skills and/or licenses or certificates preferred.
Knowledge and experience in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations.
Experience working directly with the Food and Drug Administration (FDA), as well as, ex-US regulatory authorities.
Analytical lab experience.
People and project management experience.
* Travel requirements
15 - 25%
*Physical requirements (only note if the job requires physical capacity beyond general office work)
Office based position
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.